UMIN-CTR Clinical Trial

Basic information
Public title	Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Acronym	Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Scientific Title	Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Scientific Title:Acronym	Validation Study of the S-1 dosage formula based on renal function (SCHOLAR Study: Part 2)
Region	Japan

Condition
Condition	Patients with cancer scheduled to have S-1 monotherapy
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To confirm PK and safety when S-1 calculated by B-B formula was administered
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To confirm AUC of 5-FU was valid when S-1 calculated by B-B formula was administered
Key secondary outcomes	To evaluate safety when S-1 calculated by B-B formula was administered

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. CLcr>60
Interventions/Control_2	S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. 59>CLcr>30
Interventions/Control_3	S-1 is orally administered before breakfast and blood sample is obtained 6 times from day1 to day2. S-1 is administered for 4 weeks and rest for 2 weeks. 29>CLcr>15
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Scheduled to S-1 monotherapy 2) CLcr>15mL/min 3) Age over 20 at registration 4) prior chemotherapy include S-1 does not matter 5) The presence or absence of measurable lesion does not matter. 6) PS 0, 1 7) oral intake 8) sufficient function of organs except renal function WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 AST(GOT): <= 100IU/l(or 150U/L if biliary drainage were present) ALT(GPT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=1.5mg/dl 9) written informed consent
Key exclusion criteria	1) pulmonary fibrosis and interstitial pneumonia 2) diarrhea 3) active infection 4) require blood transfusion within 14 days 5) severe complications 6) dialysis 7) massive abdominal and pleural effusion 8) Being treated with flucytosine. 9) mental disease 10) hypersensitive to 5-FU 11) Any patients judged by the investigator to be unfit to participate in the study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	hkawakubo@z3.keio.jp

Sponsor
Institute	Keio University School of medicine
Institute
Department

Funding Source
Organization	Keio University School of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine, Ethics Committee
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB	2016 Year 11 Month 10 Day
Anticipated trial start date	2016 Year 11 Month 10 Day
Last follow-up date	2018 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2019 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027507